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NCT02475759 Clinical Trial

Nutritional Prehabilitation Program and Cardiac Surgery Outcome in Pediatrics

Congenital Heart Disease Clinical Trial

Official title:
Nutritional Prehabilitation Program and Cardiac Surgery Outcome in Pediatrics. A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02475759
Other study ID # ASU 015
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 1, 2017
Est. completion date November 1, 2019

Study information
Verified date February 2022
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Nutritional Prehabilitation Program and Cardiac Surgery Outcome in Pediatrics. A randomized controlled trial.

Description:

Nutritional Prehabilitation Program and Cardiac Surgery in Pediatrics. A randomized controlled trial to compare the outcome of malnourished congenital heart surgery patients who randomly received nutritional rehabilitation program 2 weeks and 1 week before surgical intervention.

Recruitment information / eligibility
Status Completed
Enrollment 52
Est. completion date November 1, 2019
Est. primary completion date October 1, 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility The study included all infants with CHD, admitted to the cardiothoracic unit for either palliative or corrective surgery, and suffering from nutritional deficiencies with moderate or severe malnutrition . Infants received long-term nutritional prehabiliatation. Those with congenital or acquired anomaly of the gastrointestinal tract; multiple congenital anomalies; chromosomal, metabolic,or endocrine diseases; any systemic illness; or fever or infection within 1 wk before the study entry were excluded

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Nutritional perioperative prehabilitation program for two weeks
nutritional intervention received two weeks before surgical intervention
• Nutritional perioperative prehabilitation program for one week
nutritional intervention received one weeks before surgical intervention

Locations
Country Name City State
Egypt 38 abbasia, next to nour mosque, Ain Shams University Hospital, Pediatrics department Cairo

Sponsors (1)
Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary daily feeding characteristics daily feeding characteristics admission
Primary anthropometric and laboratory measure anthropometric and laboratory measure admission
Secondary length of ICU stay length of ICU stay 3weeks
Secondary duration of mechanical ventilation and extubation timing total days of mechanical ventilation 3 weeks
Secondary postoperative vital stability, surgical complication,nosocomial sepsis,inotropes withdrawal same as above admission
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